Product packaging is typically configured in a manner that defines a space or cavity to surround its contents in order to provide transportability and protection of its contents from the environment prior to opening. The product packaging can be flexible or rigid. Suitable materials, whether used singularly, in combination, or as laminates, which can be cold-sealed, heat-sealed, or flood or pattern coated with natural or synthetic adhesives or as co-extrusions to form the packaging are known and include polyethylene, polyester, polypropylene, polyurethane, polyolefin, polyvinyl alcohol, polyvinylchloride, polyvinylidene, polyamide, vinylacetate resins, BAREX®, ethylene/vinyl acetate copolymers, ethylene/ethyl acrylate copolymers, metal-vapor deposited films or sheets thereof, rubber sheets or films, expanded synthetic resin sheets or films, non-woven fabrics, fabrics, knitted fabrics, clothes, foils, papers or other suitable materials.
In many situations, the packaging associated with its product must have certain characteristics to allow effective use or performance of the package or its contents. When packaging planar or flat products, such as transdermal delivery systems, patches, bandages, films, sheets, and the like, it is generally preferable to minimize the package cavity. This is particularly true for such products that are individually packaged. Opening such packaging typically requires great care so as to not tear, cut or otherwise damage the product at the same time.
Transdermal drug delivery systems, which incorporate a drug or other agent into a carrier composition for topical administration and absorption through the skin or mucosa of the user, often require specialized or more durable packaging to maintain certain properties of the transdermal system prior to opening of its packaging. Such packaging may be a multi-layer or laminate material configured into a pouch or envelope, sealed around the product by heat sealing or an adhesive seal, in order to minimize degradation of the drug or agent and/or increase storage stability. In other instances, it may be desirable or necessary to have the product packaging made child-resistant by using tear-resistant, laminate or thicker materials for at least the outer portion of the package. For many transdermal systems, light, air or water can damage or cause degradation making it desirable to use impermeable materials, particularly for the outside layer of the package, which are opaque. Opaque packaging prevents the user from adequately determining where the patch is located in the package.
With packaging of these types, substantial force or a mechanical means such as scissors or other cutting device will be required thereby increasing the possibility of damaging the integrity of the patch upon opening the packaging. Even with packaging that provides a means to facilitate opening, such as a pre-cut edge slit or perforations, the user still cannot adequately determine where the patch is located upon opening. Moreover, inefficient tearing or opening can still result in product damage as well.
The foregoing illustrates limitations known to exist in present packages for transdermal delivery systems. The present invention provides compositions and methods for maintaining the integrity of the patch within its package that facilitates removal of the patch without risk of damage by providing one or more retention means formed of the package itself that acts to restrict movement of the patch away from the desired or predetermined area for opening the package.
The present invention relates to unit packaging for transdermal drug delivery systems particularly but not exclusively. The invention is equally applicable to the packaging of medical, veterinary and non-medical and non-veterinary patches and bandages for application to human or animal skin or mucosa.